Regulatory Affairs Specialist – International Markets

About the role

Bilim Pharmaceuticals is seeking a Regulatory Affairs Specialist to support the launch and maintenance of its pharmaceutical products in international markets. The role combines regulatory strategy, dossier preparation, and cross‑functional coordination to ensure compliance and timely market access.

Key responsibilities

• Plan and manage regulatory processes for products targeting international markets.
• Prepare and submit regulatory dossiers in EU‑CTD format, monitoring country‑specific regulations.
• Execute and monitor license renewals and variation applications.
• Establish effective communication with official authorities and business partners.
• Coordinate with R&D, Production, Quality Control and other internal departments to gather required documentation.
• Manage product labeling and packaging according to market requirements.
• Track regulatory developments and provide internal updates.

Required profile

• Bachelor’s degree in Pharmacy, Chemistry, Chemical Engineering or related field.
• 2–3 years of experience in the pharmaceutical industry, preferably in international regulatory affairs.
• Advanced proficiency in English, both written and spoken.
• Experience preparing dossiers in EU‑CTD format.
• Strong analytical, problem‑solving, communication and negotiation abilities.
• Team‑oriented with high organizational and planning skills.

Required skills

• EU‑CTD dossier preparation
• Knowledge of country‑specific regulatory requirements
• Proficiency with MS Office applications

What we offer

• Opportunity to work with a strong, collaborative team